The following data is part of a premarket notification filed by Hybritech, Inc. with the FDA for Tandem(r) Icon(r) Qsr(tm) Hcg Immuno. Assay Kit.
| Device ID | K871235 |
| 510k Number | K871235 |
| Device Name: | TANDEM(R) ICON(R) QSR(TM) HCG IMMUNO. ASSAY KIT |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | HYBRITECH, INC. 11095 TORREYANA RD. P.O. BOX 269006 San Diego, CA 92126 |
| Contact | S Kabakoff,phd |
| Correspondent | S Kabakoff,phd HYBRITECH, INC. 11095 TORREYANA RD. P.O. BOX 269006 San Diego, CA 92126 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-27 |
| Decision Date | 1987-06-03 |